New 24-month data from a study published today in the scientific journal, Neurosurgery, show that spinal cord stimulation (neurostimulation therapy) provides sustained, significant improvement in otherwise intractable, chronic leg pain, quality of life and functional capacity out to 24 months of therapy. Supported by Medtronic, Inc. (NYSE: MDT), this largest randomized, controlled neurostimulation study followed patients with chronic neuropathic leg and back pain who received spinal cord stimulation therapy along with conventional medical management to compare the results to patients who received conventional medical management alone. While the 24?month data are newly published, earlier data points from this clinical trial provided critical evidence used for the U.K.'s National Institute for Health and Clinical Excellence (NICE) final guidance, which recommends access to spinal cord stimulation therapy for patients in the United Kingdom. The updated NICE guidance concluded that the use of neurostimulation for chronic neuropathic pain is safe and effective, as well as cost?effective.

Spinal cord stimulation therapy uses an implantable medical device similar to a pacemaker to deliver electrical pulses to the epidural space in order to interrupt pain signals traveling through the nervous system from reaching the brain.

The newly published 24?month results from the study, known as PROCESS (for PROspective randomized Controlled trial of the Effectiveness of Spinal cord Stimulation), showed positive results are sustained in patients who received Medtronic neurostimulation therapy plus conventional treatments at 24 months:

• Of the 42 patients who were in the neurostimulation group from the start of the study and continued on at 24 months, 69 percent experienced a clinically significant (at least 30 percent) improvement in leg pain relief and 40 percent had a sustained 50 percent or greater improvement in leg pain relief based on the study pain scale.
• Of all 72 patients receiving neurostimulation plus conventional medical management at the 24?month study visit, including the 30 who opted to cross over from the conventional medical management alone group, 47 percent achieved 50 percent or greater improvement in the leg pain relief threshold versus only 7 percent of those receiving conventional medical management alone.

A surgical procedure was needed to resolve adverse events in 13 of the 42 patients randomized to neurostimulation who continued to receive stimulation at 24 months. As noted in the study report, the complications were benign and reversible and included electrode migration, infection and loss of paresthesia (a tingling sensation that is felt when the electrical stimulation is being delivered).

"The PROCESS study is the largest, randomized study of spinal cord stimulation published to date that shows the long?term potential for neurostimulation therapy in treating chronic and debilitating leg pain," said Richard North, M.D., neurosurgeon at Lifebridge Health Brain and Spine Institute and Professor of Neurosurgery, Anesthesiology and Critical Care Medicine (ret.) at Johns Hopkins in Baltimore, Maryland. Dr. North is a senior author on the paper and a member of the Steering Committee that was responsible for managing the PROCESS study design. "Our findings out to 24?months show that the benefits of neurostimulation therapy can be sustained for a long period of time without diminishing effectiveness. These results complement those of studies finding that carefully selected patients experience leg and back pain relief with neurostimulation. This therapy offers hope for patients whose activities are limited as a result of chronic pain that is not responsive to common treatments."

Source: medicalnewstoday.com